Data Manager/Clinical Data Coordinator

About Origin Sciences

Origin Sciences is a start-up biotechnology company based in Granta Park, just south of Cambridge. We develop our own innovative medical devices, which we use in clinical trials to collect a biobank of mucus-based biospecimens. This biobank provides clinical material for our research and development streams to assist with diagnostic development.

We are creating a minimally invasive and accurate cancer diagnostic, which will allow the NHS to focus resources on patients with more serious pathologies. Our motivations are to reduce NHS waiting times, enable earlier cancer detection and reduce unnecessary investigations performed on healthy patients.

Our cancer diagnostic is analogous to blood-based liquid biopsies. However, we have the advantage of evaluating material that was collected closer to the pathology of interest.

About the Role

We are seeking a Data Manager/Clinical Data Coordinator to undertake data management activities and to assist the clinical team with trial coordination. This will include the management of data acquired from our EDC system, and ensuring the highest data quality in interventional studies, whilst adhering to Standard Operating Procedure (SOP), Good Clinical Practice (GCP) and data security protocols.

The successful candidate will liaise with clinicians for the data collection and with the wet lab team for sample data management.

Responsibilities

• To clean, standardise and prepare data for statistical analysis.
• Building and management of individual study databases and the manipulation of data received.
• Data validation of prospectively acquired data.
• To raise data queries and liaise with relevant centres.
• To train clinical trials personnel, where necessary, in order to maintain and improve the quality of data being collected.
• To maintain documentation in the TMF.
• To ensure that all documentation of databases and systems are in line with GCP, ICH regulations e.g. by maintaining version control logs.
• To assist regulatory team to provide data required by the Sponsor, R&D, MHRA and HRA e.g. the Annual Progress & Development Safety Update Reports.
• Ad-hoc administrative tasks to assist clinical teams.

• PhD or Master’s degree in a STEM subject (e.g. Bioinformatics, Genetics, Mathematics, Statistics, Engineering, Computer Sciences or a relevant discipline).
• Experience working with an Electronic Data Capture (EDC) system
• Experience working with clinical trial documentation and data derived from clinical trial samples.
• Ability to summarise key results of analysis and communicate actionable outcomes.
• Understanding of data management best practices.
• Understanding of regulatory environment impacting clinical data management (GCP & UK GDPR).

Desirable:

• Understanding of colorectal and/or gynaecological cancer development and genetics, and current clinical practice.
• Previous experience in clinical trial management and/or trial monitoring at sites or remotely.
• Experience in scientific programming, in particular python and/or R.
• Git and version control.

• 25 days of holiday
• Pension contribution
• Hybrid working option